The tongue and soft palate play a major role in production of snoring and obstructive sleep apnea. Without their participation, these symptoms could not be present. Hence, it is imperative to have knowledge about these structures, which play an important role in snoring and obstructive sleep apnea, to understand our invention. The tongue is a muscular organ, without bones, and richly supplied with nerves and blood vessels (FIG. 3a). The tongue also serves as a natural means of cleaning one's teeth by its multi-directional movement capability. It is kept moist by saliva and mucous glands of the oral cavity.
The average length of the adult human tongue is 10 cm (4.5 inches) from the oropharynx to the tip. It is divided by a V-shaped shallow groove called the sulcus terminalis, into an anterior two thirds and a posterior one third with the foramen cecum (FIG. 1) in the center of the angle. The tongue is lined by thick stratified squamous epithelium which continues with the rest of the oral mucosa. This mucosal covering the upper surface of the tongue is thrown into several projections called the lingual papillae in the anterior two thirds of the tongue. These papillae give the roughness to the dorsal surface of the tongue and helps hold our inventive device, firmly. In the posterior one third, there are no papillae; but, there are numerous discrete masses of lymphoid follicles projections called lingual tonsils.
There are three types of papillae: fungiform (mushroom like), filiform (thread like), circumvallate papillae (cup and saucer shaped) and foliate papillae (rare in humans). Underneath the papillae, there are mucous and serous glands, pockets of adipose tissue, a layer of skeletal muscle and connective tissue. Many of these papillae have taste buds which carry taste sensations to the CNS. Von Ebner's glands (also called gustatory glands) are located around circumvallate and foliate papillae in the tongue. They secrete lingual lipase digestive enzyme which flushes particulate from the moat to enable the taste buds to respond rapidly to fresh ingested food and the taste of drinks. The secretions of these glands also inhibit the growth of bacteria.
The tongue is made up of five intrinsic muscles: superior, inferior, longitudinal, transverse, and vertical muscles not attached to any bone, and four extrinsic muscles: genio, hyo, stylo, and palato glossus muscles that are attached to bones (FIG. 3a). The skeletal muscles in the tongue arranged in three different planes. This allows the tongue to perform a number of complex movements in every direction. While asleep in the supine position, all the tongue muscles relax; the muscle mass of the tongue moves back due to weight and gravitational pull resulting in obstruction of the air way causing snoring and obstructive sleep apnea (FIGS. 1, 2, 3).
The palate is located on the roof of the mouth and is made of boney hard palate and muscular, aponeurotic soft palate (FIG. 4). The flexible skeleton for the soft palate is provided by the aponeurosis of tensor palati muscle. There are five pairs of palatine muscles of the soft palate that are involved in the movement of the palate and uvula which participate in the production of snoring. They are: 1: Tensor palati, 2: Levator palati, 3: Palatopharyngeus from the upper surface, 4: with the uvular muscles within the upper surface, and 5: Palatoglossus from the lower surface. The thin muscles with aponeurosis of the soft palate lose their tone during sleep, lengthen in size, move toward the pharynx and the back of the tongue, and act as a resonating instrument like a drum or thick string reverberating with the passage of air during respiration, resulting in snoring during sleep.
The region of the tongue underneath the tip and blade of the tongue called the sublingual region (206, FIG. 4). Here, the oral mucosa is very thin with a rich plexus of veins (seen by lifting the tongue in a mirror) with openings of the submandibular, sub maxillary, mucous and serous glands. Because of its thin mucosal lining, therapeutic agents are easily and rapidly absorbed and delivered to the systemic circulation. That is why the sublingual region is selected as the route of administration of many therapeutic agents. This is the distinct expedient and efficacious route of administration of nitroglycerin to a patient suffering from an acute attack of chest pain from angina pectoris. If the tablet swallowed, the medication is completely neutralized by the detoxification process of the digestive system enzymes and the liver.
The tongue plays a primary role in the production of obstructive sleep apnea (FIG. 3). The dorsal surface of the tongue is constantly in contact with the hard and soft palate except at the posterior surface, which is inclining, and comes in contact with the epiglottis and oropharynx leading to obstructive sleep apnea. In the present invention, the tongue glove anti-snoring device covers the entire, visible, free tongue surface and will come in contact with the palate when the mouth is dosed with breathing occurring through the nose.
The palate forms the roof of the mouth and is made up of two regions: the hard palate in front; the soft palate behind (FIG. 4). The hard palate is formed by the palatine processes of the maxillae. The horizontal plates of the palatine bones behind it continue with the soft palate. It is the soft palate that plays a role in snoring; and it plays a role with the tongue in obstructive sleep apnea. The soft palate is suspended from the posterior border of the hard palate, and extends downwards and backwards between the oral and nasal parts of the pharynx. It consists of mucous membrane enclosing an aponeurosis, muscular fibers, vessels, nerves, lymphoid tissue and mucous glands.
Its superior border is attached to the posterior margin of the hard palate, and its sides are blended with the pharynx. Its inferior border is free, which contributes to snoring. The uvula is a diminutive conical process suspended from the middle of its lower border and has two curved borders of mucous membrane. It contains muscular fibers (palatoglossal arch) and extends laterally and downwards from each side of the base of the uvula. A fibrous lamella, the palatine aponeurosis is attached to the posterior border of the hard palate and to the inferior surface of the hard palate behind the palatine crest which supports the palatine muscles and gives strength to the soft palate. The muscles of the palate (208, FIG. 4) include a levator and a tensor of the palate; the muscles underlying the palatoglossal and palatopharyngeal folds and extending into the palate itself; and the muscle of the uvula. The soft palate plays an important role in snoring. The flexible skeleton for the soft palate is provided by the aponeurosis of tensor palati muscle on which the soft palate moves when relaxed during snoring.
Snoring, hypopnea and obstructive sleep apnea are caused by the vibrating soft palate, the soft tissue of the nasal, oral and laryngeal pharynx; along with the relaxed tongue moving backwards towards the oral and laryngeal pharynx; thus, blocking of the air passageway through the pharynx. Snoring is an inspiratory sound which arises in the course of a person's sleep and is due to the narrowing of the naso-oro- and laryngo-pharyngeal airway and is mostly produced by the soft palate. The sounds of snoring are generated by vibration of soft tissues of oropharynx which involves the soft palate, uvula, tongue, lips, the posterior faucial pillars of the tonsils, pharyngeal folds, posterior, lateral pharyngeal wall and epiglottis in the upper airway.
Many causes for the narrowing of the nasal pharyngeal airway exist, especially during sleep, besides the flaccid soft palate and the tongue. People who snore rarely make snoring sounds when breathing while awake in the same position that is associated with snoring when asleep (FIGS. 1, 2, 3). The reason being that the wide-awake, conscious person has watchful control over the various muscles of the upper airway so as to prevent the vibrations that cause snoring to occur (FIG. 1). During sleep, the motor neurons that control skeletal muscles are inhibited from sending instructions to make them active and increase the tone of these muscles. This physiological process in sleep results in flaccid muscles that permit soft tissue to sag and collapse into the pharyngeal airway resulting in snoring and obstructive sleep apnea strikes (FIGS. 2, 3).
It has been estimated that up to 45% of all adults snore, sporadically with about 25% being constant snorers. It is known that snoring increases with advancing age and it has been observed that about 50% of men and 40% of women are habitual snorers by the age of 60 (Lugaresi, et al, “Snoring: Pathogenic, Clinical and Therapeutic Aspects”, Reported in Principles and Practice of Sleep Medicine (Kryger et al, Editors 1989) at pp. 494-500). With increasing weight gain and epidemic of obesity, the snoring and obstructive sleep apnea is bound to increase.
TYPES OF SLEEP APNEA: There are three types of sleep apnea. They are as follows:
1. Obstructive sleep apnea is the common form of the condition when the tissues of the naso-oro-laryngeal-pharynx obstruct breathing during sleep. These pauses in breathing, called apneas, usually last 20 to 40 seconds. There are more than 20 million people who suffer from obstructive sleep apnea in the U.S., and its occurrence in the adult population is estimated to be 3-4% in women and 6-7% in males. People who gain weight, develop obesity, have craniofacial syndromes (mostly genetic), have repairs of the cleft palate, Down Syndrome, small mandibles, receding chins, etc. have a higher risk of developing obstructive sleep apnea than most individuals. The present invention is intended to treat the conditions causing obstructive sleep apnea.
2. Central sleep apnea is due to neurological condition resulting from a head injury, stroke, various central nervous system disorders, and/or heart failure. Patients with central sleep apnea should avoid using sedatives, narcotics, and alcohol. Treating the primary etiology will, in most cases, eliminate the condition. Unfortunately, the primary etiology may be terminal.
3. Mixed sleep apnea is due to physical oropharyngeal airflow obstruction associated with central (CNS) etiology. It is a rare condition, but is the most dangerous form of sleep apnea and it is difficult to treat. The present invention is provided to treat this form of obstructive sleep apnea, as well.
Symptoms of obstructive sleep apnea are:                frequent cessation of breathing (apnea) during sleep (sleeping spouse or companion may notice repeated silences from your side of the bed        then sudden awakenings to restart breathing with choking or gasping during sleep to get air);        loud snoring;        waking up in a sweat during the night due to lack of oxygen and resulting carbon dioxide build up;        waking up restless in the morning after a night's sleep with or without headaches, sore throat, or dry mouth in the mornings;        daytime sleepiness including falling asleep at improper times, such as during driving, at work, at meetings and conferences; mood changes such as irritability, anxiety and depression; trouble concentrating; forgetfulness reduced and        dwindling sex drive; unexplained weight gain; increased urination and/or nocturia; frequent heartburn, gastro-esophageal reflux disease (GERD); and heavy night sweats.        
Studies by Lee, et al. have shown that the oxygen desaturation detected in all patients with obstructive sleep apnea. It is not found in simple snorers (Lee C H, Mo J H, Kim B J, Kong I G, Yoon I Y, Chung S, Kim J H, Kim J W, Arch Otolaryngol Head Neck Surg. Evaluation of soft palate changes using sleep video fluoroscopy in patients with obstructive sleep apnea. 2009 eb; 135(2):168-72). Studies show that the soft palate was considerably elongated and angulated in patients with obstructive sleep apnea, even when awake. Hence, the treatment of snoring should be differentiated for the sake of treatment: 1: to prevent production of sound during sleep, 2: to correct the obstructive sleep apnea with serious health consequences. The present invention is intended for treatment of both conditions.
There are no effective FDA approved drug treatments for obstructive sleep apnea. Nevertheless, a clinical trial of antidepressants mirtazapine (brand names: REMERON, AVANZA, ZISPIN) has shown some hopeful results in the treatment of obstructive sleep apnea. Mirtazapine is not a serotonin uptake inhibitor (SSRI) reuptake inhibitor. It disinhibits dopamine and norepinephrine activity in various parts of the brain, notably in the pleasure centers such as the ventral tegmental area, causing a pronounced antidepressant and anxiolytics response due to the release of the neurotransmitters dopamine and norepinephrine.
SSRIs such as fluoxetine, tryptophan, protriptyline; oral methylxanthine and theophylline (chemically similar to caffeine), amphetamines stimulants; to anti-narcoleptic medications such as modafinil are also tried. A course of anti-inflammatory steroids such as prednisone (or another glucocorticoid drug) is given to reduce the lymphoid tissue of the naso-oropharyngeal air passages if enlargement of the lymphoid tissue is found and the allergic conditions are suspected.
A basic treatment for snoring and obstructive sleep apnea involves having the patient sleep in the prone position or on his/her side. Sometimes this is stimulated by sewing an object into the back of the snorer's clothes. In obese patients, treatment includes weight loss. Along with these treatments, it is recommended that the patient avoid use of CNS depressing drugs, cigarettes, or alcohol prior to bedtime to prevent or reduce the loss of oropharyngeal muscle tone.
Obstruction due to enlarged tonsils or adenoids may indicate the need for their removal. In some cases, surgical repair of a deviated nasal septum has been shown to improve snoring. A reduced pharyngeal passageway may also be caused by a lack of muscle tone. Other anatomical conditions contributing to the narrowing of the nasal, oral, and laryngeal pharyngeal air passageway include choanal atresia, chrono polyp, nasal septal deviation, nasal and pharyngeal cysts, macroglossia, retrognathia, and micrognathia and countless other etiologies. Snoring and obstructive sleep apnea might be aggravated by alcoholic drinks or drugs (such as tranquilizers, hypnotic, sleeping pills, and antihistamines) taken prior to bedtime. Smoking is also held responsible for snoring, since cigarettes may irritate the mucus membranes of the upper airway and oropharynx; causing swelling and increased mucus production. Where snoring is caused by nasal allergy or an upper respiratory tract infection, these conditions may be treated with antiallergenic treatment (Douglas N J “The Sleep Apnoea/Hypopnoea Syndrome And Snoring”, British Medical journal, 1993, Vol. 306:1057-60; Leung et al, “The ABZzzz's of Snoring” Post Graduate Medicine (Sep. 1, 1992).
Anti-snoring and anti-obstructive sleep apnea devices abound. Some of them are shown to be effective when they pull or hold the mandible (lower jaw) forward and upward and, elevate the tongue as the muscles of the mandible relax, so that the tongue does not occlude the air passageway drifting, inferiorly and posteriorly while sleeping so as to prevent the passage of air. Some of the devices are just attached to the tip of the tongue with vacuum and held in position by dental bites while asleep. Most anti-snoring devices accomplish this task by moving the lower jaw forward and holding that position against a rigid upper dental component, which is fixed to the upper teeth in the immobile maxilla and to the lower teeth in the mandible.
The disadvantages in using the above prior art devices, is that they require expert, qualified, licensed lab services for fitting of the anti-snoring device to the user's mouth. Such devices could cause permanent irremediable changes in the bite of the user and permanently alter the jaw position, and it requires a dentist to closely monitor the anti-snoring device's fitting. There is a need for an anti-snoring device that does not rigidly bind to the dental structures of the user's mouth and that does not require professional supervision or assistance in its fabrication, monitoring of the dental bite changes and mandibular changes. In addition, the anti-snoring device should not pit the lower jaw against the upper jaw. These devices do not include an intra-oral dental overlay to support the tongue against the palate and keep the palate of the user's mouth from reverberating (snoring) during mouth breathing. Our invention overcomes these draw backs.
Snoring and obstructive sleep apnea is also be managed by the use of a positive pressure generator and facemask. In this procedure, a mask covers the nose and mouth or just nose or mouth is used and it delivers air under pressure. The standard method is known as “Continuous Positive Airway Pressure” (CPAP) treatment, which requires the patient wear a mask through which air is blown into the nostrils in order to keep the airway open. Patient compliance is poor due to discomfort and side effects. CPAP pneumatically splints the upper airway. Use of this devices cause the subject to become non-compliant due to the difficulty in its use due to discomfort during sleep. Problems that may occur with CPAP include: restless sleep, dryness of nose, throat, nasopharyngeal tract, cough, excessive dreaming during early use, nasal congestion, runny nose, sneezing, irritation of the eyes and the skin on the face, abdominal bloating, and leaks around the mask because it does not fit properly.
The person may be able to limit or stop some of the side effects; the doctor may be able to adjust one's CPAP to reduce or eliminate problems and make sure the mask or nasal prongs fit properly (air should not leak around the mask); and/or the patient may use a humidifier or a corticosteroid nasal spray medicine to reduce nasal congestion, irritation, and drainage.
Users of this method of treatment may need to talk to a doctor about trying a CPAP machine that will help to reduce discomfort caused by too much constant pressure in the user's nose. If this does not improve discomfort, ask your physician about trying a bi-level positive airway pressure machine (BiPAP-VPAP or variable positive airway pressure) which uses a different air pressure when you breathe in than when you breathe out. BiPAP may work better than standard CPAP for treating obstructive sleep apnea in people who have heart failure. Almost every patient of snoring and obstructive sleep apnea dislikes using this bulky cumbersome, bothersome equipment; hence, compliance is low.
A more recent treatment option for obstructive sleep apnea includes the implantation of rigid inserts in the soft palate to provide structural support; it is both invasive and is only effective for mild to moderate cases of obstructive sleep apnea. Alternative treatments are even more invasive and drastic including tracheotomy, genioglossus advancement or stimulator, hyoid suspension, tongue reposition, and tissue ablation (somnoplasty or uvulopalatopharyngoplasty.
If all else fails, sleep apnea treated by maxillomandibular advancement where lower part of patients face is moved forward approximately 12 millimeters; reduction of the size of the soft palate; laser-assisted uvulopalatoplasty; and/or reduction of the tongue base either with laser excision or radiofrequency ablation or by hyoid bone suspension in the neck. In rare intractable cases, a tracheotomy is the only effective last resort treatment for sleep apnea.
Due to many associated disadvantages, complications and high failure rate, these tissue ablation methods and radical surgeries need to be considered as a last resort. Surgical removal of the uvula, distal portion of the soft palate, the anterior tonsillar pillars, adenoids, tonsils and the redundant lateral pharyngeal wall mucosa is said to increase the size of the air passageway allowing unobstructed movement of air through the pharynx during sleep. Rates of success of the uvulopalatopharyngoplasty are reported to be in a range from 15% to 65%. (Douglas, “The Sleep Apnoea/Hypopnoea Syndrome And Snoring”, British Medical journal, 1993, Vol. 306:1057-60).
Obstructive sleep apnea causes high blood pressure, depression, irregular heartbeats, heart failure, coronary artery disease, and stroke. If the person is overweight, bariatric surgery may help with weight loss, which may improve snoring and sleep apnea.
U.S. Pat. No. 5,569,679 discloses the use of nasal solution 10%-16% of methylsulfonylmethane (MSM) drops for the treatment of anti-snoring method. It is a nasal spray, too simplistic to treat complicated anatomically related snoring with or without obstructive sleep apnea whose pathophysiology is rarely in the nose.
U.S. Pat. No. 5,921,241 discloses an anti-snoring device including a moldable dental overlay for covering the lower teeth of the user and for maintaining the tongue in contact with the palate to prevent air flow from causing the palate to reverberate during mouth breathing.
U.S. Patent Application Publication Number: US 2004/0153127 A1 invention provides electrical stimulation that causes the oropharyngeal muscles to contract during sleep using one or more micro stimulators injected into or near these muscles or the nerves which innervate them.
U.S. Patent Application Publication Number: US 2007/0233276 A1 describes the method and apparatus that includes placing a tissue contractor within the tongue tissue. This is an invasive procedure and may create discomfort and complication after surgery.
U.S. Pat. No. 6,418,933 B1 discloses an anti-snoring device that has maxillary and mandibular bite forms with outwardly extending pivots which are mounted to the bite forms by frameworks which are at least partially embedded in the bite forms.
U.S. Pat. No. 5,499,633 shows two bite forms which may be joined so that the user's mandible projects forwardly of its normal position in order to reduce snoring.
U.S. Patent Application Publication Number: 2005/0178392 A1 discloses a small piece of cloth tape or other porous hypo allergenic material with a hypo allergenic adhesive on the back that is affixed to the lips before sleeping. This may not be effective in preventing the vibration of the soft palate and snoring with or without obstructive sleep apnea.
U.S. Pat. No. 7,016,736 B2 discloses a submental electrical stimulation of the supra hyoid muscles at the floor of the mouth, but does not address the snoring due to vibration of the soft palate and uvula.
Numerous management techniques have been described, and none of these treatments have proved adequate; most of the therapies are inadequate to treat snoring and obstructive sleep apnea and cumbersome to use. Surgery for the condition is filled with fear and complications besides the high cost and high rate of failure. Hence, the snoring with or without obstructive sleep apnea remains a serious slow evolving health problem. With increasing obesity, snoring and obstructive sleep apnea is increasing in the general population along with type II diabetes. Accordingly, there has been a need for improved management techniques to reduce or eliminate snoring and obstructive sleep apnea by using simple and safe methods. The devices in the present invention designed to be used to treat snoring and obstructive sleep apnea with minimal or no complications, having the least disadvantages, being affordable, and having the highest compliance.